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SarcomaPhase 2NCT00041236

Exatecan Mesylate in Treating Patients With Advanced Soft Tissue Sarcoma

A Phase 2 study testing exatecan mesylate in people with Sarcoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 10 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients who have advanced soft tissue sarcoma. Read more about this study

Who is it for?
Ages 15 to 75 years
Conditions the study is for
Sarcoma
What is being tested?
exatecan mesylate
How many people
39 participants
Where
10 sitesin 4 countries
Study dates
May 2002to Dec 2004
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed soft tissue sarcoma
  • Malignant fibrous histiocytoma
  • Liposarcoma
  • Rhabdomyosarcoma
  • Synovial sarcoma
  • Malignant paraganglioma
  • Fibrosarcoma
  • Leiomyosarcoma
  • Angiosarcoma including hemangiopericytoma
  • Malignant peripheral nerve sheath tumor
  • Unclassified sarcoma
  • Miscellaneous sarcoma including mixed mesodermal tumors of the uterus
  • The following tumor types are excluded:
  • Gastrointestinal stromal tumor
  • Chondrosarcoma
  • Malignant mesothelioma
  • Neuroblastoma
  • Osteosarcoma
  • Ewing's sarcoma
  • Embryonal rhabdomyosarcoma
  • Prior chemotherapy for metastatic disease required
  • One line of combination chemotherapy containing anthracycline OR
  • No more than 2 single-agent regimens including anthracycline
  • Adjuvant chemotherapy not considered first line unless tumor progresses within 6 months after treatment
  • Must have 1 measurable lesion
  • Clinical evidence of progression within 6 weeks prior to study
  • Osseous lesions and pleural effusions not considered measurable
  • No known or symptomatic CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • 15 to 75

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.8 mg/dL
  • Albumin at least 2.5 g/dL

Renal:

  • Creatinine no greater than 1.4 mg/dL OR
  • Creatinine clearance greater than 65 mL/min

Cardiovascular:

  • No history of severe cardiovascular disease

Other:

  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for up to 6 months after study participation
  • No other severe medical illness, including psychosis
  • No other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy
  • No other concurrent cytotoxic therapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No radiotherapy to the sole measurable lesion
  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • No other investigational drugs for 28 days prior to, during, and for 28 days after completion of study drug
  • No other concurrent anticancer therapy

Trial locations and contacts

10 sites in 4 countries.

10 sites in 4 countries

Germany6 sites

  • Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

    Berlin, D-13122

  • Universitatsklinikum Carl Gustav Carl Carus

    Dresden, D-01307

  • Universitaetsklinikum Essen

    Essen, D-45122

  • Universitaets-Krankenhaus Eppendorf

    Hamburg, D-20246

  • Medizinische Hochschule Hannover

    Hanover, D-30625

  • Eberhard Karls Universitaet

    Tübingen, D-72076

Other trials in Germany

Belgium2 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • U.Z. Gasthuisberg

    Leuven, B-3000

Other trials in Belgium

Denmark1 site

  • Aarhus University Hospital - Aarhus Sygehus - Norrebrogade

    Aarhus, DK-8000

Other trials in Denmark

Slovakia1 site

  • National Cancer Institute - Bratislava

    Bratislava, 833 10

Other trials in Slovakia

About this study

Official title: Exatecan As Second-Line Treatment In Advanced Adult Soft Tissue Sarcoma: A Phase II - Study Of The EORTC Soft Tissue And Bone Sarcoma Group

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients who have advanced soft tissue sarcoma.

Read the detailed description

OBJECTIVES:

  • Determine the anticancer activity of exatecan mesylate, in terms of objective response and duration of response, in patients with advanced soft tissue sarcoma.
  • Determine the safety of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to histological diagnosis (leiomyosarcoma vs other histologies).

Patients receive exatecan mesylate IV over 30 minutes daily on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 weeks until disease progression. After disease progression, patients are followed every 12 weeks for survival.

PROJECTED ACCRUAL: A total of 32-50 patients (16-25 per stratum) will be accrued for this study.

Conditions
Sarcoma
Being tested
exatecan mesylate
Keywords
adult angiosarcoma, adult fibrosarcoma, adult leiomyosarcoma, adult liposarcoma, adult neurofibrosarcoma, adult synovial sarcoma, stage IV adult soft tissue sarcoma, recurrent adult soft tissue sarcoma, adult malignant fibrous histiocytoma, adult malignant hemangiopericytoma, adult rhabdomyosarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma, uterine leiomyosarcoma
Medical subject headings
Sarcoma, Hemangiosarcoma, Fibrosarcoma, Leiomyosarcoma, Liposarcoma, Neurofibrosarcoma, Sarcoma, Synovial, Histiocytoma, Malignant Fibrous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exatecan mesylateDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startMay 2002
  3. Primary completionDec 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00041236
Sponsor's protocol ID
EORTC-62006
Other IDs
EORTC-62006
Status last verified
Jul 2012
First submitted
8 Jul 2002
Last updated
18 Jul 2012
Results posted
No

Publications

  • Reichardt P, Nielsen OS, Bauer S, Hartmann JT, Schoffski P, Christensen TB, Pink D, Daugaard S, Marreaud S, Van Glabbeke M, Blay JY; EORTC Soft Tissue and Bone Sarcoma Group. Exatecan in pretreated adult patients with advanced soft tissue sarcoma: results of a phase II--study of the EORTC Soft Tissue and Bone Sarcoma Group. Eur J Cancer. 2007 Apr;43(6):1017-22. doi: 10.1016/j.ejca.2007.01.014. Epub 2007 Mar 1.

    PubMed 17336054

  • Pink D, Reichardt P, Nielsen OS, et al.: Exatecan (DX-8951f), a new topoisomerase I - inhibitor, is inactive in heavily pretreated patients (pts.) with advanced soft tissue sarcoma (STS): a phase II study of the EORTC Soft Tissue and Bone Sarcoma Group. [Abstract] J Clin Oncol 23 (Suppl 16): A-9058, 830s, 2005.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing exatecan mesylate in people with Sarcoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 10 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany, Belgium, Denmark, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00041236, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2012.

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